Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT05862818
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2023-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Food Timing Reduce Your Diabetes Risk?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2023-04-17', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in glucose tolerance between Meal Conditions and Shift Work', 'timeFrame': '24 hours', 'description': 'Glucose incremental area under the curve (AUC) from mixed meal tests'}, {'measure': 'Difference in diet-induced thermogenesis between Meal Conditions and Shift Work', 'timeFrame': '24 hours', 'description': 'Postprandial energy expenditure incremental area under the curve (AUC) from mixed meal tests'}, {'measure': 'Difference in plasma triglyceride level between Meal Conditions and Shift Work', 'timeFrame': '24 hours', 'description': 'Triglyceride area under the curve (AUC) over 24 hours'}], 'secondaryOutcomes': [{'measure': 'Difference in insulin sensitivity between Meal Conditions and Shift Work', 'timeFrame': '24 hours', 'description': 'Insulin sensitivity index derived from Oral Minimal Model'}, {'measure': 'Difference in beta-cell function between Meal Conditions and Shift Work', 'timeFrame': '24 hours', 'description': 'Beta-cell function index derived from Oral Minimal Model'}, {'measure': 'Difference in 24-h glycemia between Meal Conditions and Shift Work', 'timeFrame': '24 hours', 'description': 'Glucose area under the curve (AUC) based on CGM over 24 hours'}, {'measure': 'Difference in postprandial incretin level between Meal Conditions and Shift Work', 'timeFrame': '24 hours', 'description': 'Incretin incremental area under the curve (AUC) from mixed meal tests'}, {'measure': 'Difference in substrate oxidation between Meal Conditions and Shift Work', 'timeFrame': '24 hours', 'description': 'Postprandial substrate oxidation incremental area under the curve (AUC) from mixed meal tests'}, {'measure': 'Difference in plasma free fatty acids level between Meal Conditions and Shift Work', 'timeFrame': '24 hours', 'description': 'Free fatty acids area under the curve (AUC) over 24 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glucose tolerance', 'Diet-induced thermogenesis', 'Fat tolerance'], 'conditions': ['Dietary Habits']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test whether food timing impacts metabolic health in healthy participants.\n\nParticipants will:\n\n* complete 2 inpatient stays\n* be provided with test meals\n* have frequent blood draws', 'detailedDescription': 'The investigators aim to investigate the influence of different food timing, without changing 24-h caloric and nutrient intake, on glucose and fat tolerance and energy expenditure in healthy people on a simulated day or night shift.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy with no acute or chronic medical and psychiatric disorders\n* BMI: 18.5-29.9 kg/m2\n\nExclusion Criteria:\n\n* Smokers, current tobacco or e-cigarette use\n* Drug or alcohol dependency\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT05862818', 'briefTitle': 'Can Food Timing Reduce Your Diabetes Risk?', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Can Food Timing Reduce Your Diabetes Risk?', 'orgStudyIdInfo': {'id': '2023P001063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Day shift protocol with diet A', 'description': 'Day shift protocol with diet A condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes.', 'interventionNames': ['Behavioral: Day shift protocol - Diet order A-B', 'Behavioral: Day shift protocol - Diet order B-A']}, {'type': 'EXPERIMENTAL', 'label': 'Day shift protocol with diet B', 'description': 'Day shift protocol with diet B condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes.', 'interventionNames': ['Behavioral: Day shift protocol - Diet order A-B', 'Behavioral: Day shift protocol - Diet order B-A']}, {'type': 'EXPERIMENTAL', 'label': 'Night shift protocol with diet A', 'description': 'Night shift protocol with diet A condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes.', 'interventionNames': ['Behavioral: Night shift protocol - Diet order A-B', 'Behavioral: Night shift protocol - Diet order B-A']}, {'type': 'EXPERIMENTAL', 'label': 'Night shift protocol with diet B', 'description': 'Night shift protocol with diet B condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes.', 'interventionNames': ['Behavioral: Night shift protocol - Diet order A-B', 'Behavioral: Night shift protocol - Diet order B-A']}], 'interventions': [{'name': 'Day shift protocol - Diet order A-B', 'type': 'BEHAVIORAL', 'description': 'Research participants will be assigned to day shift condition and Diet A-B order condition.', 'armGroupLabels': ['Day shift protocol with diet A', 'Day shift protocol with diet B']}, {'name': 'Day shift protocol - Diet order B-A', 'type': 'BEHAVIORAL', 'description': 'Research participants will be assigned to day shift condition and Diet B-A order condition.', 'armGroupLabels': ['Day shift protocol with diet A', 'Day shift protocol with diet B']}, {'name': 'Night shift protocol - Diet order A-B', 'type': 'BEHAVIORAL', 'description': 'Research participants will be assigned to simulated night shift condition and Diet A-B order condition.', 'armGroupLabels': ['Night shift protocol with diet A', 'Night shift protocol with diet B']}, {'name': 'Night shift protocol - Diet order B-A', 'type': 'BEHAVIORAL', 'description': 'Research participants will be assigned to simulated night shift condition and Diet B-A order condition.', 'armGroupLabels': ['Night shift protocol with diet A', 'Night shift protocol with diet B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Frank Scheer, PhD', 'role': 'CONTACT', 'email': 'fscheer@bwh.harvard.edu', 'phone': '617-732-14'}, {'name': 'Frank Scheer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Ioannis Lempesis, MD, PhD, PhD', 'role': 'CONTACT', 'email': 'timedstudy@bwh.harvard.edu', 'phone': '6177326256'}], 'overallOfficials': [{'name': 'Frank Scheer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Frank AJL Scheer, PhD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}